A Phase 3 interventional study of Maraviroc and placebo in HIV Infection, Cardiovascular Disease and Inflammation, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-24.
Sponsored by University of California, San Francisco · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 52 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
Drug: Maraviroc
Drug: placebo
For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.
For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.
Percent Change in FMD
endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
Time frame: Baseline, 24 weeks
| Milestone | Maraviroc | Placebo |
|---|---|---|
| Started | 26 | 26 |
| Completed | 24 | 25 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Adverse event | 1 | 0 |
endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery
| percent change in FMD | Maraviroc | Placebo |
|---|---|---|
| Percent Change in FMD | 0.57 ± 2.1 | -0.05 ± 2.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Maraviroc | — | 1/26 (3.8%) | 0/26 (0%) |
| Placebo | — | 0/26 (0%) | 0/26 (0%) |
| Event | Maraviroc | Placebo |
|---|---|---|
| hepatocellular carcinomaSurgical and medical procedures | 1/26 | 0/26 |
per protocol
| Age, Continuous(years) | Maraviroc | Placebo | Total |
|---|---|---|---|
| Median | 52 (45 to 60) | 52 (47 to 57) | 52 (45 to 59) |
| Sex: Female, Male(Participants) | Maraviroc | Placebo | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 25 | 26 | 51 |
| Region of Enrollment(participants) | Maraviroc | Placebo | Total |
|---|---|---|---|
| United States | 26 | 26 | 52 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco